Quidel Respiratory Test Kit Solana® SARS-CoV-2 96 Tests CLIA Non-Waived - KT/1 - M958-KT
Quidel Respiratory Test Kit Solana® SARS-CoV-2 96 Tests CLIA Non-Waived - KT/1 - M958-KT
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Quidel Respiratory Test Kit Solana® SARS-CoV-2 96 Tests CLIA Non-Waived - KT/1 - M958-KT
| Item Id | 1182301 |
| MF Id# | M958 |
| Brand | Solana® |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Classified | CLIA Non-Waived |
| Contents 1 | (96) Process Buffer Tubes, (96) Empty Reaction Tubes, 1 Tube Negative Control, 1 Tube Positive Control, (8) Master Mix Tubes, (100) Nasal Swabs, (100) Universal Transport Media |
| For Use With | For use with Solana Instrument |
| HCPCS | U0002 (Disclaimer) |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Lot_Tracking_Flag | N |
| Number of Tests | 96 Tests |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab Sample |
| Specialty | Molecular |
| Storage Requirements | Keep Frozen |
| Supplier_ID | 487993 |
| Test Format | Tube Format |
| Test Kit Type | Standard |
| Test Method | Isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) Assay |
| Test Name | SARS-CoV-2 |
| Test Type | Molecular Diagnostic |
| Time to Results | 30 Minute Results |
| UNSPSC Code | 41116144 |
Features
- Solana SARS-CoV-2 Assay is for use under an FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate complexity tests
- The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider
- Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information
- The Solana SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Solana SARS-CoV-2 Assay and/or the Solana Instrument
- The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using isothermal Reverse Transcriptase — Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which is performed in the Solana instrument